Method for fusing a human or animal joint as well as fusion device and tool set for carrying out the method

ABSTRACT

The fusion device for fusing a synovial joint of a human or animal patient, in particular a human facet joint, finger joint or toe joint, includes two pin-shaped anchorage portions and arranged therebetween a stabilization portion. The anchorage portions include a thermoplastic material which is liquefiable by mechanical vibration. The stabilization portion preferably has a surface which is equipped for enhancing osseointegration. The anchorage portions have a greater thickness and a greater depth than the stabilization portion. Then the fusion device is pushed between the articular surfaces and mechanical vibration, in particular ultrasonic vibration, is applied to the proximal face of the fusion device. Thereby the liquefiable material is liquefied where in contact with the bone tissue and penetrates into the bone tissue, where after re-solidification it constitutes a positive fit connection between the fusion device and the bone tissue.

BACKGROUND OF THE INVENTION Field of the Invention

The invention is in the field of medical technology and concerns amethod for fusing a human or animal joint (arthrodesis), wherein thejoint is a synovial joint, i.e. an articulation between two bones eachone comprising a cartilaginous articular surface, the movement of thearticular surfaces relative to each other being lubricated by synoviawhich is confined in an articular capsule. The method is in particularsuitable for fusing small synovial joints, such as human facet joints,joints of human hand and foot (including fingers and toes), sacroiliacjoints, sternoclavicular joints, sternocostal articulations orcostovertebral joints. The invention further concerns a fusion deviceand a tool set for carrying out the method.

Fusion of synovial joints serves e.g. as treatment for pain caused bydegenerative or traumatic damage of the articular surfaces. The pain isrelieved by preventing articular movement, i.e. by fixing the jointmechanically, usually followed by fusion of the originally articulatingbones through osseoconduction (bone growth bridging the two articularsurfaces). In the context of the present description the term “fusion”shall not only mean complete immobilization of the joint to be followedby osseoconduction (orthopedic indication), but, in particular whenapplied to a facet joint, also partial and/or temporal immobilization tostabilize a decompression procedure or for fixing a foramen distractioninduced by flexion of the spine in a specific position (e.g.Mekka-position) of the patient or induced by application of distractinginstruments (neurologic indication. Furthermore, such facet fusion maybe used to allow spine fixation after milder correction of spinalcurvature deformities or to support spine stabilization after correctionof spondylotic conditions.

It has been known at least since 1949 (“A mortised transfacet bone blockfor lumbosacral fusion” by Earl D. McBride, Journal of Bone and JointSurgery, volume 31-A, pp. 385-399, 1949) that fusion of the facet jointsof lumbosacral vertebrae is a valid and simple way for immobilizing theconcerned vertebrae relative to each other, in particular in connectionwith a disc operation. For fusing the facet joints McBride suggeststransfacet bone blocks which are impacted under distraction intorectangular, undercut mortises having a depth of about 3 to 5 mm andextending from the laminae below to the facets above to form aninterlaminal supporting strut.

Later authors propose fusion of facet joints through introduction offusion devices between the articular surfaces of the joint, which fusiondevices usually reach deeper (e.g. 10 to 20 mm) into the joint than thebone blocks described by McBride. Such fusion devices are e.g. block- orwedge-shaped elements or cages being introduced between the articularsurfaces, or they are cylindrical or cone-shaped and are introduced in acorresponding bore extending substantially parallel to the articularsurfaces, i.e. constituting two opposite grooves of which one extends ineach one of the articular surfaces. In most cases it is suggested todecorticate the articular surfaces and to use fusion devices made ofbone tissue or in the form of cages filled with bone material or bonereplacement material such enhancing and accelerating the bone growthdesired for full stabilization of the mechanically fused joint. In thetime between the implantation of the fusion device and the achievementof full joint stabilization by a bony connection between the two bones,it is mainly friction which holds the fusion device in place anddesirably reduces joint movement to a degree, which is high enough forenabling the desired bone growth. Most authors are of the opinion thatfor securing the position of the fusion device and for achieving thedesired reduction in joint movement it is desirable or even necessary tooversize the fusion device for achieving a press-fit on implantationand/or to equip the fusion devices with locking means. Disclosed lockingmeans range form flange-shaped extensions on the proximal side of block-or wedge-shaped elements or cages, which extensions are fixed to thedorsal or lateral surfaces of the articular processes (disclosed e.g. inUS 2005/0124993, Chappuis), to retention flanges (disclosed e.g. in US2006/0111782, Petersen), retention ridges or protrusions (US2009/0036927, Vestgaarden), threads (disclosed e.g. in US 2006/0190081,Kraus, or WO 2007/120903, Blackstone), or longitudinal ridges arrangedon more or less cylindrical fusion device surfaces to be in contact withthe bone tissue of the articular surfaces and possibly serving forgrooving these surfaces on introduction of the fusion device into thejoint (disclosed e.g. in US 2006/0085068, Barry). Further known lockingmeans are separate locking elements such as e.g. staples, or cableswhich are arranged to hold the two articular processes forming the facetjoint together e.g. by being wound around outer process surfaces or byreaching through translaminar bores (disclosed e.g. in US 2006/0190081).Such separate locking elements can also be used for facet joint fusionby themselves, i.e. without the further above described fusion devicebeing introduced between the articular surfaces.

Mechanical immobilization of a synovial joint by simply pushing a fusiondevice, e.g. a wedge shaped fusion device, between the articularsurfaces is sufficient for joint fusion only if the articulating bonesare biased against each other by an unyielding bone and/or cartilagestructure as is the case e.g. for the facet joints and the sacroiliacjoint and possibly for the sternocostal articulations or costovertebraljoints. For fusion of synovial joints in which the articulating bonesare connected only by ligaments, which relax under tension, sufficientmechanical immobilization is possible only with a fusion device which isfirmly connected to the articular surfaces or which is combined withadditional elements holding the articulating bones together. The latteris in particular the case for the joints of the human hand and foot(including fingers and toes) and for the sternoclavicular joints.

Methods and tool sets for facet joint fusion with the aid of a fusiondevice are described e.g. in the publications US 2009/0076551(Petersen), US 2009/0036927 (Vestgaarden), WO 2008/097216 (Marino), WO2007/120903 (Blackstone) and US 2006/0085068 (Barry).

SUMMARY OF THE INVENTION

It is the object of the invention to provide a method for fusing humanor animal synovial joints, in particular for fusing small synovialjoints such as human facet joints, joints of human hand and foot(including fingers and toes), sacroiliac joints, sternoclavicularjoints, sternocostal articulations, or costovertebral joints. It is afurther object of the invention to provide a fusion device and a toolset for carrying out the method. The improvement of the method and thefusion device according to the invention over known methods for the samepurpose regards in particular the stability of the fusion deviceimmediately after implantation, the enablement of bone growth by theimplanted fusion device and/or the simplicity of the implantationprocedure. This means that, after implantation, the fusion deviceaccording to the invention is to be able to remain in place and toimmobilize the joint to a sufficiently high degree without the necessityof additional locking elements and, all the same and if so desired, thefusion device is to enable optimal osteoconduction between the two bonesof the joint and preferably optimal osseointegration of the fusiondevice in the bone tissue, and, all the same, the implantation of thefusion device is to be simple and suitable for minimally invasivesurgery.

These objects are achieved by the method, the fusion device, and thetool set as defined in the corresponding claims.

The following description concentrates in particular on fusion of humanfacet joints. This does not constitute a limitation of the teachingaccording to the invention to facet joint fusion, wherein the describedmethod, fusion device and tool set is particularly suitable for fusionof the lumbar facet joints (L1/L2 to L5/S1). However, it is easilypossible for one skilled in the art to adapt the disclosed method, aswell as the forms and dimensions of the fusion device and of the tools,not only for application in other facet joints (in particular of thethoracic and cervical region) but also for applications regarding othersynovial joints, in particular the synovial joints as mentioned in thefirst paragraph of the present description.

The method and the fusion device according to the invention arepreferably based on the known implantation technique according to whichan implant comprising a material having thermoplastic properties andbeing liquefiable by mechanical vibration is anchored in hard tissue, inparticular in bone tissue, by applying such vibration to the implant, inparticular ultrasonic vibration. These implantation techniques as wellas implants being suitable for the implantation techniques are disclosede.g. in the publications U.S. Pat. No. 7,335,205, U.S. Pat. No.7,008,226, US 2006/0105295, and US-2008/109080 as well as in the USprovisional applications U.S.-60/983,791, and U.S.-61/049,587, which arenot published yet. The disclosure of all the named publications andapplications is enclosed herein by reference.

The basis of the above named implantation techniques is the in situliquefaction of a thermoplastic material having mechanical propertiessuitable for a mechanically satisfactory anchorage of the fusion devicein the bone tissue, wherein the material in its liquefied state has aviscosity which enables it to penetrate into natural or beforehandprovided pores, cavities or other structures of the bone tissue, andwherein an only relatively small amount of the material is liquefiedsuch that no unacceptable thermal load is put on the tissue. Whenre-solidified, the thermoplastic material which has penetrated into thepores, cavities or other structures constitutes a positive fitconnection with the bone tissue.

Suitable liquefaction connected with an acceptable thermal loading ofthe tissue and giving suitable mechanical properties of the positive fitconnections is achievable by using materials with thermoplasticproperties having a modulus of elasticity of at least 0.5 GPa and amelting temperature of up to about 350° C. and by providing suchmaterial e.g. on an implant surface, which on implantation is pressedagainst the bone tissue, preferably by introducing the implant in a boneopening which is slightly smaller than the implant or by expanding theimplant in a bone opening which originally is slightly larger than theimplant (expansion e.g. by mechanically compressing or buckling theimplant). During implantation, the implant is subjected to vibration ofa frequency preferably in the range of between 2 and 200 kHz (preferablyultrasonic vibration) by applying e.g. the sonotrode of an ultrasonicdevice to the implant. Due to the relatively high modulus of elasticitythe thermoplastic material transmits the ultrasonic vibration with suchlittle damping that inner liquefaction and thus destabilization of thefusion device does not occur, i.e. liquefaction occurs only where theliquefiable material is in contact with the bone tissue and is therewitheasily controllable and can be kept to a minimum.

Instead of providing the liquefiable material on the surface of theimplant (disclosed e.g. in U.S. Pat. No. 7,335,205 or U.S. Pat. No.7,008,226), it is possible also to provide the liquefiable material in aperforated sheath and to liquefy it within the sheath and press itthrough the sheath perforation to the surface of the fusion device andinto the pores or cavities of the bone tissue (disclosed e.g. in U.S.Pat. No. 7,335,205, U.S. Pat. No. 7,008,226 and U.S. provisionalapplication 61/0495,879) and/or it is possible to liquefy theliquefiable material between two implant parts of which one is vibratedand the other one serves as counter element, the interface between thetwo implant parts being positioned as near as possible to the bonetissue (as disclosed in the U.S. provisional applications 60/983,791 and61/049,587).

In specific embodiments of the method according to the invention, it ispossible to exploit energy types other than vibrational energy forcreating the local thermal energy needed for the liquefaction of thematerial with thermoplastic properties. Such other energy types are inparticular rotational energy turned into friction heat in substantiallythe same manner as the vibrational energy, or electromagnetic radiation(in particular laser light in the visible or infrared frequency range),which radiation is preferably guided through the material withthermoplastic properties and locally absorbed by an absorber beingcontained in the material with thermoplastic properties or beingarranged adjacent to this material. For specific embodiments of thefusion device and specific applications it may be possible to use othermethods for anchoring the device in the joint than anchorage with theaid of a thermoplastic material which is liquefied to penetrate into thebone tissue. Such other methods are e.g. simple positioning of thedevice between the correspondingly prepared articular surfaces, whereinfor retaining the device in the position in which it is implanted, thedevice is dimensioned for a press-fit and/or specific device partscomprise per se known retention means such as e.g. barbs, resilientprotrusions, threads or cutting edges able to groove the bone tissue onimplantation.

Preferred embodiments of the fusion device according to the inventioncomprise at least two device portions: at least one anchorage portion(preferably two) equipped for anchorage of the fusion device in the bonetissue using one of the above shortly described anchorage methods, andat least one stabilization portion which may be equipped for furtheringosseointegration of the fusion device in the joint. These embodiments ofthe fusion device are preferably implanted essentially between thesuitably prepared articular surfaces of the joint and the deviceportions are designed to delimit at least partly at least oneosteoconduction region, i.e. a preferably central region in which thetwo articular surfaces face each other directly (without a deviceportion therebetween), and, if decorticated, at a small distance fromeach other.

According to the preferred embodiment of the method according to theinvention, the above described preferred embodiment of the fusion deviceis pushed between the articular surfaces in an implantation direction.The fusion device has a depth in the implantation direction, which depthextends from a proximal device face being adapted for holding andguiding the fusion device with a tool during the implantation and forapplying the vibration (or possibly other energy) to the fusion device,to a distal device end facing forward during the implantation. Thefusion device further has a width (parallel to the articular surfaces)and a thickness or thickness profile (perpendicular to the articularsurfaces), width and thickness extending perpendicular to theimplantation direction. The fusion device portions (anchorage andstabilization portions) are arranged alternately beside each other inthe direction of the device width, the anchorage portion(s) having alarger thickness and preferably a larger depth than the stabilizationportion(s). The thickness difference between the anchorage portion(s)and the stabilization portion(s) amounts preferably to a few millimetersand grooves are provided in the articular surfaces for accommodation ofthe thicker anchorage portion(s).

The anchorage portion(s) has(have) preferably the form of a pin with atapering distal end, the stabilization portion(s) has(have) preferablythe form of a plate or wedge and is joined to a lateral side of theanchorage portion(s). Osteoconduction regions are delimited by concavedevice contours, i.e. by at least one lateral side of an anchorageportion and at least one distal or proximal face of at least onestabilization portion, and/or by at least one through opening in astabilization portion.

The anchorage portion comprises the liquefiable material. Thestabilization portion may also comprise a liquefiable material, whichmay be the same as or different from the liquefiable material of theanchorage portion, but may further comprise or consist of anon-liquefiable material (e.g. a metal), and it preferably comprisessurfaces with a coating and/or surface structure which is suitable forenhancing osseointegration.

The overall depth and width of the fusion device is adapted to the sizeof the articular surfaces of the joint to be fused. Therein it isadvantageous for the fusion device not to take up more than about halfto about three quarters of the articular surfaces and that theosteoconduction regions amount to at least about a fifth of thearticular surfaces. The thickness of the stabilization portion(s) ischosen to easily fit into the gap between the two articular surfaces, ifapplicable in their prepared state (after decortication or removal ofcartilage).

There is no necessity for the fusion device according to the inventionto comprise any bone or bone replacement material; however, it may ofcourse do so. Bone growth enhancing material such as e.g. allograft orautograft bone material, bone replacement material, sponges, BMPcarriers, if used, are preferably arranged in the osteoconduction regionof the fusion device, wherein the named materials may be positionedbetween the prepared articular surfaces before positioning and anchoringthe fusion device or wherein the named materials may be preassembledwith the fusion device. For such preassembly, device surfaces of theconcave device contour delimiting the osteoconduction region may carryretention means such as e.g. grooves or dents for retaining the namedmaterial.

The preferred embodiment of the method according to the inventioncomprises the following two steps:

Fixation step: fixation of the joint in a desired position, wherein thearticular surfaces are positioned directly against each other (closedjoint gap) or have a desired distance from each other (the fixation stepis not necessary if the joint capsule is firm and taut enough for takingover the fixation function).

Preparation step: Removal of cartilage and possibly decortication of thearticular surfaces, at least for preparation of grooves adapted to theanchorage portion(s) of the fusion device (removal of the cartilage fromthe entire articular surface is possible but not necessary; preparationof grooves is not necessary, if the anchorage portion(s) comprisesself-reaming structures, i.e. is equipped as disclosed in US2006/0105295, whose disclosure is incorporated herein by reference);

Implantation step: Introduction of the fusion device between thearticular surfaces and application of energy, preferably mechanicalvibration, to the fusion device either during introduction (if theliquefiable material is to be liquefied while being pressed against thebone tissue) or after introduction (if the liquefiable material is to beliquefied inside a perforated sheath and pressed through the sheathperforation and/or if the liquefiable material is liquefied between twodevice parts).

Finishing step: tools are separated from the fusion device and, ifapplicable, fixation of the joint is released.

The articular surfaces remain fixed relative to each other during thepreparation step and the implantation step. This means that the fusiondevice is not meant to distract the joint and any desired relevant jointdistraction has to be achieved with the aid of per se known means beforethe fixation step.

Further embodiments of the fusion device and the method according to theinvention may vary from the above shortly described preferredembodiments in that:

Anchorage portions (preferably two) and stabilization portions(preferably one) of the fusion device constitute separate device parts(multi-part or preferably three-part fusion device as opposed to theabove described one-part fusion device), wherein the anchorage portionsare positioned and anchored between the articular surfaces in the jointfirst, and the stabilization portion is then mounted on the proximalends of the anchorage portions, or wherein the stabilization portion ispositioned between the articular surfaces first and the anchorageportions are then pushed through or past the stabilization portion andanchored in the bone tissue beside and/or beyond the stabilizationportion (see FIGS. 12 to 14).

The fusion device does not comprise any stabilization portion, i.e. itcomprises only one anchorage portion or a plurality of anchorageportions preferably being implanted simultaneously.

The liquefiable material is provided on one side of the anchorageportion(s) only such that the fusion device is anchored in one articularsurface only. This may provide enough mechanical joint immobilizationfor joint fusion, in particular in the case of unyieldingly biasedjoints such as facet joints and sacroiliac joints. A similar one-sidedanchorage can be achieved with anchorage portions comprising theliquefiable material all around, but by not removing the articularcartilage layer on the one articular surface and therewith renderinganchorage through the liquefiable material virtually impossible.

The fusion device comprises e.g. two anchorage portions and onestabilization portion constituting a one-part device or a three-partdevice and the fusion device is not implanted between the articularsurfaces but is implanted such that the device width is orientedsubstantially perpendicular or at an oblique angle to the articularsurfaces, the anchorage portions being anchored not in grooves preparedin the articular surfaces but in openings, e.g. bores in the bone tissueadjacent to the articular surfaces (see FIGS. 19 and 20).

BRIEF DESCRIPTION OF THE DRAWINGS

A plurality of exemplary embodiments of the method, the fusion deviceand the tool set according to the invention are illustrated in thefollowing Figs., wherein:

FIGS. 1A to 1C show different sections through a preferred embodiment ofthe fusion device according to the invention, the one-part fusion devicecomprising two anchorage portions and one stabilization portion arrangedbetween the anchorage portions;

FIGS. 2A to 2D show four successive phases of a preferred embodiment ofthe method according to the invention, wherein the fusion deviceaccording to FIGS. 1A to 1C is implanted between the articular surfacesof e.g. a human facet joint;

FIG. 3 is a flow chart for the method as illustrated in FIGS. 2A to 2D;

FIGS. 4A to 4H show eight tools of an exemplary embodiment of the toolset according to the invention, each tool being illustrated viewed fromthe side and towards the distal tool end, the tool set being suitablefor implantation of the fusion device according to FIGS. 1A to 1C withthe method as illustrated in FIGS. 2A to 2D;

FIG. 5 is a flow chart of a method in which the whole tool set accordingto FIGS. 4A to 4H are used;

FIGS. 6A to 6C show a preferred embodiment of a guide bush and a cutterfor the tool set according to FIGS. 4A to 4H, wherein the cutter guideis integrated in the guide bush and the cutter;

FIG. 7 is a larger scale section through the fusion device according toFIGS. 1A to 1C, the fusion device being mounted on the distal end of thevibration tool;

FIG. 8 is a three-dimensional illustration of a fusion device similar tothe one according to FIGS. 1A to 1C;

FIGS. 9 to 11 show further exemplary embodiments of the fusion deviceaccording to the invention, wherein in these embodiments the arrangementof the liquefiable material (and therewith the applicable anchoringtechnique) is different from the arrangement in the fusion deviceaccording to FIGS. 1A to 1C;

FIG. 12 shows a further exemplary embodiment of the fusion deviceaccording to the invention, the device comprising three separate partsto be introduced in the joint in succession and to be assembled withinthe joint (three-part or multi-part device);

FIGS. 13A to 13D show two further embodiments of the fusion deviceaccording to the invention, which are based on the same principle as thedevice according to FIG. 12;

FIGS. 14A to 14C illustrate methods for connecting in situ the anchorageportions with the stabilization portions of the fusion devices accordingto FIG. 12 or FIGS. 13A to 12D;

FIGS. 15 to 18 show further exemplary embodiments of the fusion deviceaccording to the invention, which fusion devices comprise numbers ofanchorage portions and stabilization portions which are different fromthese numbers of the fusion device according to FIGS. 1A to 1C;

FIGS. 19 and 20 illustrate implantation of a fusion device comprisingtwo anchorage portions and a stabilization portion, wherein the fusiondevice is not implanted between the articular surfaces but across thegap between the articular surfaces.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A to 1C show a first exemplary embodiment of the fusion deviceaccording to the invention. The illustrated embodiment is particularlysuited for fusion of a human lumbar facet joint, but, if correspondinglyadapted, may also serve for fusion of other human facet joints or ofother small synovial joints in a human or animal patient. FIG. 1A showsthe fusion device in section perpendicular to its thickness (parallel tothe implantation direction I; section line A-A in FIGS. 1B and 1C), FIG.1B shows the fusion device in section perpendicular to its depth(implantation direction I perpendicular to the paper plane; section lineB-B in FIGS. 1A and 1C), and FIG. 1C shows the fusion device in sectionperpendicular to is width (parallel to the implantation direction I;section line C-C in FIGS. 1A and 1B). FIG. 1A also shows veryschematically, outlines of an articular surface (dash-dotted line S) andthe position of the implanted fusion device in relation thereto.

The fusion device comprises two pin-shaped anchorage portions 1 and astabilization portion 2 situated between the two anchorage portions 1.Distally, the anchorage portions 1 and the stabilization portion 2 formtogether a concave device contour which delimits an osteoconductionregion 3. In this osteoconduction region 3 some bone growth furtheringmaterial may be positioned either before or after implantation of thedevice, wherein, for preassembly of the device and such material, devicesurfaces in the region of the named concave device contour may beequipped with spikes, barbs or other surface structures suitable forholding the bone growth furthering material. The fusion device has anoverall depth D, an overall width W and a thickness profile comprisingtwo general thicknesses (T1 of the anchorage portions 1 being largerthan T2 of the stabilization portion 2).

The stabilization portion 2 is e.g. made of a non-liquefiable (in thesense of the anchoring technique) material, e.g. of a metal (e.g.titanium or titanium alloy), of a ceramic material (e.g. zirconiumoxide) or of a thermoset polymer or thermoplastic polymer (e.g. PEEK)having a melting temperature, which is sufficiently higher than themelting temperature of the liquefiable material. The stabilizationportion may also be made of a composite material comprising e.g. atrabecular metal (e.g. titanium or tantalum) and a thermoset orthermoplastic polymer. The composite material comprising endless fibers(e.g. carbon fibers) molded into a plastic material (e.g. PEEK OPTIMAPolymer™) with the aid of the composite flow molding process by theSwiss firm “icotec” is a further suitable material for the stabilizationportion. Non-resorbable polymeric or composite materials used for thestabilization portion are preferably equipped with osseointegrationsupporting means like e.g. a coating of hydroxy apatite.

The anchorage portions 1 comprise the liquefiable material at least ontheir surfaces to come into contact with the bone tissue or are e.g.made of this material, wherein, if the anchorage is to be achieved withthe aid of mechanical vibration, the named surfaces preferably compriseenergy directors (not shown) e.g. in the form of protruding humps oraxial ridges. The anchorage portions 1 are joined to the stabilizationportion 2 by adhesion or, as illustrated on the left hand side of thefusion device of FIG. 1A, via a rough surface or surface structuresuitable for forming together with the liquefiable material a positivefit connection. For a stronger connection between the anchorage portions1 and the stabilization portion 2 the latter may reach into or throughthe anchorage portions 1 as illustrated on the right hand side of thefusion device of FIG. 1A. The fusion device is manufactured by e.g.positioning the stabilization portion 2 into a corresponding mould andinjection-molding the anchorage portions 1 to or around thestabilization portion 2.

The fusion device embodiment as illustrated in FIGS. 1A to 1C mayfurther comprise a bridge or edge portion (not shown) connecting the twoproximal ends of the anchorage portions 1 and covering the proximal faceand possibly up to about 20% of the depth of the stabilization portionand consisting of the liquefiable material. Such a bridge or edgeportion of an implanted fusion device constitutes a polymer seam tightlyclosing the joint gap. In a further embodiment of the fusion devicesimilar to the one shown in FIGS. 1A to 1C the stabilization portion aswell as the anchorage portions are made entirely of the liquefiablematerial (see also FIG. 8).

The proximal face 4 of the fusion device is preferably adapted to a rimportion of the articular surfaces by being curved. Preferably theproximal face 4 comprises means for the fusion device to be held by atool, e.g. by a vibration tool. Such means are e.g. axial openings orbores 5 arranged e.g. in the region of the anchorage portions 1 andcooperating with corresponding protrusions provided on a distal toolface (see also FIG. 4).

The two thicknesses T1 and T2 are e.g. in the range of 1 to 3 mm and 3to 8 mm. If the fusion device is to be used for fusing a human facetjoint, its overall depth is in the range of 5 to 20 mm, preferably 7 to20 mm, its overall width in the range of 5 to 20 mm, preferably 5 to 15mm.

Suitable liquefiable materials to be used for the anchorage portions 1and possibly for part of the stabilization portion (bridge portion) orthe whole stabilization portion are thermoplastic polymers, e.g.:resorbable polymers such as polymers based on lactic and/or glycolicacid (PLA, PLLA, PGA, PLGA etc.) or polyhydroxy alkanoates (PHA),polycaprolactone (PCL), polysaccharides, polydioxanes (PD)polyanhydrides, polypeptides or corresponding copolymers or compositematerials containing the named polymers as a component; ornon-resorbable polymers such as polyolefines (e.g. polyethylene),polyacrylates, polymethacrylates, polycarbonates, polyamides, polyester,polyurethanes, polysulfones, polyarylketones, polyimides,polyphenylsulfides or liquid crystal polymers LCPs, polyacetales,halogenated polymers, in particular halogenated polyolefines,polyphenylensulfides, polysulfones, polyethers or equivalent copolymersor composite materials containing the named polymers as a component.

Specific embodiments of degradable materials are Polylactides like LR706PLDLLA 70/30, R208 PLDLA 50/50, L210S, and PLLA 100% L, all ofBöhringer. A list of suitable degradable polymer materials can also befound in: Erich Wintermantel und Suk-Woo Haa, “Medizinaltechnik mitbiokompatiblen Materialien und Verfahren”, 3. Auflage, Springer, Berlin2002 (in the following referred to as “Wintermantel”), page 200; forinformation on PGA and PLA see pages 202 ff., on PCL see page 207, onPHB/PHV copolymers page 206; on polydioxanone PDS page 209. Discussionof a further bioresorbable material can for example be found in CABailey et al., J Hand Surg [Br] 2006 April; 31(2):208-12.

Specific embodiments of non-degradable materials are: Polyetherketone(PEEK Optima, Grades 450 and 150, Invibio Ltd), Polyetherimide,Polyamide 12, Polyamide 11, Polyamide 6, Polyamide 66, Polycarbonate,Polymethylmethacrylate, Polyoxymethylene. An overview table of polymersand applications is listed in Wintermantel, page 150; specific examplescan be found in Wintermantel page 161 ff. (PE, Hostalen Gur 812, HöchstAG), pages 164 ff. (PET) 169 ff. (PA, namely PA 6 and PA 66), 171 ff.(PTFE), 173 ff. (PMMA), 180 (PUR, see table), 186 ff. (PEEK), 189 ff.(PSU), 191 ff (POM—Polyacetal, tradenames Delrin, Tenac, has also beenused in endoprostheses by Protec).

The liquefiable material having thermoplastic properties may containforeign phases or compounds serving further functions. In particular,the thermoplastic material may be strengthened by admixed fibers orwhiskers (e.g. of calcium phosphate ceramics or glasses) and suchrepresent a composite material. The thermoplastic material may furthercontain components which expand or dissolve (create pores) in situ (e.g.polyesters, polysaccharides, hydrogels, sodium phosphates), compoundswhich render the fusion device opaque and therewith visible for X-ray,or compounds to be released in situ and having a therapeutic effect,e.g. promotion of healing and regeneration (e.g. growth factors,antibiotics, inflammation inhibitors or buffers such as sodium phosphateor calcium carbonate against adverse effects of acidic decomposition).If the thermoplastic material is resorbable, release of such compoundsis delayed. If the device is to be anchored not with the aid ofvibration energy but with the aid of electromagnetic radiation, theliquefiable material having thermoplastic properties may locally containcompounds (particulate or molecular) which are capable of absorbing suchradiation of a specific frequency range (in particular of the visible orinfrared frequency range), e.g. calcium phosphates, calcium carbonates,sodium phosphates, titanium oxide, mica, saturated fatty acids,polysaccharides, glucose or mixtures thereof.

Fillers used may include degradable, osseostimulative fillers to be usedin degradable polymers, including: β-Tricalcium phosphate (TCP),Hydroxyapatite (HA, <90% crystallinity; or mixtures of TCP, HA, DHCP,Bioglasses (see Wintermantel). Osseo-integration stimulating fillersthat are only partially or hardly degradable, for non degradablepolymers include: Bioglasses, Hydroxyapatite (>90% crystallinity),HAPEX®, see S M Rea et al., J Mater Sci Mater Med. 2004 September;15(9):997-1005; for hydroxyapatite see also L. Fang et al., Biomaterials2006 July; 27(20):3701-7, M. Huang et al., J Mater Sci Mater Med 2003July; 14(7):655-60, and W. Bonfield and E. Tanner, Materials World 1997January; 5 no. 1:18-20. Embodiments of bioactive fillers and theirdiscussion can for example be found in X. Huang and X. Miao, J BiomaterApp. 2007 April; 21(4):351-74), J A Juhasz et al. Biomaterials, 2004March; 25(6):949-55. Particulate filler types include: coarse type: 5-20μm (contents, preferentially 10-25% by volume), sub-micron (nanofillersas from precipitation, preferentially plate like aspect ratio >10, 10-50nm, contents 0.5 to 5% by volume).

FIGS. 2A to 2D, as exemplary embodiment of the method according to theinvention, illustrate the implantation of a fusion device similar to theone shown in FIGS. 1A to 1C in a joint, e.g. in a human facet joint,whose articular surfaces are but slightly convex/concave, whereinanchorage of the anchorage portions of the device is achieved with theaid of mechanical vibration. FIG. 2A shows in section perpendicular tothe implantation direction the articular surfaces of the joint. Thesearticular surfaces are, at least in a healthy and undamaged state, fullycoated with articular cartilage 10.

In a fixation step the articular surfaces of the facet joint are fixedrelative to each other e.g. by positioning a guide tool against aposterior or lateral surface of the articular processes, such that thedistal tool face 21′ reaches across the joint gap, and forcing spikes 33arranged on this distal tool face 21′ into the process bone on bothsides of the joint gap. If, in the fixation step, a gap between thearticular surfaces being wider than the natural gap is to be fixed, acorresponding distracter tool (not illustrated in FIGS. 2A to 2D) isintroduced in the gap before positioning the guide tool, or thevertebral column of the patient is brought into a correspondingly bentposition.

In the preparation step being carried out after the fixation step, twobores are drilled substantially parallel to the articular surfaces andparallel to each other, the bores constituting the grooves 11 in thearticular surfaces and serving for accommodating the anchorage portionsof the fusion device. The bores preferably have a diameter beingsufficiently large for the cartilage layer and at least part of thecortical bone beneath the cartilage layer to be grooved. Furthermore, itis preferable to also remove the cartilage layer and possibly somecortical bone between the two bores, to a depth which is at least aslarge as the depth of the stabilization portion of the fusion device andpreferably as large as the overall depth of the fusion device (includingthe osteoconduction region). Depending on the anchorage technique, thediameter of the bores may need to be slightly smaller than the diameterof the anchorage portions. If the stabilization portion also comprisesliquefiable material the thickness of the stabilization portion may beadapted to the gap between the possibly prepared articular surfaces suchthat the stabilization portion can be introduced into this gap withoutsubstantial friction, i.e. such that virtually no liquefaction occurs,or such that on introduction under vibration the stabilization portionis anchored in the articular surfaces substantially in the same manneras the anchoring portions. The space between the articular surfacescreated in the preparation step (FIG. 2B) is optionally at leastpartially filled with a material capable of furthering bone growth (e.g.bone paste or bone replacement material) in order to improveosteoconduction between the two articular surfaces and possiblyosseointegration of the fusion device.

In the implantation step, the fusion device is inserted between theprepared articular surfaces with the anchorage portions being introducedinto the bores and the fusion device is simultaneously vibrated with theaid of a vibration tool which is applied to the proximal face of thefusion device (FIG. 2C). Due to the contact of surfaces of the vibratingfusion device with the non-vibrating bone tissue at least in the regionof the grooves 11, the liquefiable material provided on these devicesurfaces is liquefied and penetrates into the bone tissue, where, aftersolidification, it constitutes a positive fit connection between thebone tissue and the fusion device, in particular the anchorage portionsthereof (illustrated by squiggly lines 12 in FIG. 2C).

After positioning and anchoring the fusion device in the joint, the toolused for the anchorage is separated from the fusion device and the jointfixation is released (finishing step, e.g. removal of guide tool) asshown in FIG. 2D. Obviously the anchored fusion device as shown in FIG.2D is securely kept in its position and prevents not only articulationof the joint but also movements due to shearing forces in alldirections, due to torque, and due to bending forces in planes otherthan articulating planes. However, due to the relatively low modulus ofelasticity of the thermoplastic material constituting the anchorage, thepositive fit connection between the fusion device and the bone tissue ofthe fused joint still allows very small movements of the two bonesrelative to each other, which micro movements are known to enhanceosseointegration and osteoconduction.

FIG. 3 is a flow chart of the method as illustrated in FIGS. 2A to 2Dand shows the fixation step, the preparation step, the implantation stepand the finishing step. If fixation of the joint by the joint capsule issufficient, the fixing step and the finishing step are not necessary.The preparation step is not a necessary step (see further below), i.e.the implantation step may be carried out immediately after the fixationstep. In any case, some preparation (e.g. decortication of a larger areaof the articular surfaces) may be carried out before the fixation step.

FIGS. 4A to 4H show the tools of an exemplary embodiment of the tool setaccording to the invention, the tool set serving for carrying out themethod according to the invention. The tool set is e.g. suitable forimplanting a fusion device as illustrated in FIGS. 1A to 1C in a method,whose main steps are illustrated in FIGS. 2A to 2D and in FIG. 3. Eachtool of the tool set is shown viewed from the side and against thedistal tool end. The tools, which are shown in the sequence of their usein the implantation method are the following: a gap finder 20 (FIG. 4A),a guide bush 21 (FIG. 4B), a drill guide 22 (FIG. 4C), a drill 23 (FIG.4D), a cutter guide 24 (FIG. 4E), a cutter 25 (FIG. 4F), a control tool26 (FIG. 4G), and a vibration tool 27 (FIG. 4H). Tools 20 and 21 areapplicable in the fixation step, tools 22 to 26 in the preparation step,and tool 27 in the implantation step.

The gap finder 20 is equipped for finding and possibly distracting thegap between the two articular surfaces between which the fusion deviceis to be introduced and for marking the orientation of this gap. Forthis purpose it carries on its distal end at least one flat and bluntprotrusion (e.g. two protrusions 30) which is suitable for being pushedbetween the articular surfaces and possibly for temporarily keeping themat a predetermined distance from each other. Depending on the form ofthe articular surfaces of the joint to be fused, the protrusions 30 ofthe gap finder 20 may not extend fully axially as illustrated but may beslightly bent (in the range of about 10°) away from the axial direction,which e.g. for introduction into a facet joint is advantageous. The gapfinder 20 may further comprise an axial bore 31 for accommodating aK-wire (not shown) being used for locating the gap between the articularsurfaces to start with, and for guiding the gap finder 20 towards thegap, wherein the gap finder 20 is pushed along the wire. The gap finder20 has a cross section with one distinguished larger diameter in thedirection of the gap being located with the aid of the distalprotrusions or the direction defined by the protrusions respectively(the cross section is e.g. oblong as illustrated or oval but notcircular nor square), this cross section being adapted to the fusiondevice as well as to inner or outer cross sections of the further toolsof the tool set in a way to be elaborated further down.

The guide bush 21 comprises an axial tunnel 32 for guiding the guidebush 21 along the gap finder 20, i.e. the tunnel has a cross sectionwhich corresponds to the cross section of the gap finder 20. As alreadydiscussed in connection with FIGS. 2A to 2D, the guide bush 21 carrieson its distal end face a plurality of short and sharp spikes 33 orblades suitable for fixing the guide bush to the bone on either side ofthe articular surfaces and at the same time for fixing the articularsurfaces relative to each other. The spikes are forced into the bonetissue e.g. by applying a punch 34 to its proximal end. The drill guide22 comprises two axial bores 35 adapted in diameter and distance fromeach other to the diameter and the position of the anchorage portions ofthe fusion device. The outer cross section of the drill guide 22 isadapted to the cross section of the axial tunnel 32 of the guide bush 21such that guidance of the drill guide 22 in this axial tunnel positionsthe drill guide 22 exactly over the gap between the articular surfaces.The drill guide 22 further comprises a stop shoulder 36, e.g. at itsproximal end or inside the axial bores.

The drill 23 being equipped for drilling cartilage and bone tissue has adiameter being adapted to the diameter of the axial bores 35 of thedrill guide 22 and an axial length from a distal end to a depth stop,e.g. a region of increasing diameter 37, which axial length is greaterthan the axial length of the drill guide from a distal end to the stopshoulder 36 by about the depth to which the fusion device is to beintroduced between the articular surfaces.

The cutter guide 24 has substantially the same outer cross section asthe drill guide 22 and comprises an axial tunnel 38 which has an oblongcross section being adapted to the proximal face of the stabilizationportion of the fusion device. The cutter guide 24 further comprises astop shoulder 39, e.g. on its proximal end as illustrated or inside theaxial tunnel 38.

The cutter 25 is preferably a rotating tool equipped for removingcartilage and possibly bone tissue from between the two bores producedwith the aid of the drill guide 22 and the drill 23. The cutter 25 ise.g. a drill having a cross section adapted to the smaller extension ofthe cross section of tunnel 38 and preferably being mounted to arotational drive such that it can be laterally displaced or pivotedrelative to a housing of the drive in the plane of the longer extensionof the cross section of tunnel 38 in a very limited manner. The cuttermay also be designed as a correspondingly shaped punching tool beinge.g. driven by ultrasonic vibration. Such punching tools are disclosedin the publication US 2008/269649, the disclosure of which is enclosedherein by reference. The cutter 25 further comprises a depth stop 40cooperating with the stop shoulder 39 of the cutter guide 24. The axiallength of the cutter 25 from its distal end to the depth stop 40 islarger than the axial length of the cutter guide 24 from its distal endto the stop shoulder 39 by the depth to which the tissue between the twobores is to be removed, preferably at least by the depth of thestabilization portion of the fusion device.

The control tool 26 has a distal end similar to the vibration tool 27carrying the fusion device (see below) but slightly undersized andadjoining this distal end it has a cross section which is the same asthe outer cross section of drill guide and cutter guide. The controltool 26 advantageously carries depth marks (not shown) where itprotrudes from the guide bush 21, the marks indicating depths to whichthe distal end of the control tool is introduced in the gap between thearticular surfaces.

The vibration tool 27 is e.g. a sonotrode which is equipped for beingcoupled to a vibration drive, e.g. of an ultrasonic device. The distalend of the vibration tool 27 is equipped for holding the fusion device Fand for transmitting vibration to the fusion device. For the latterfunction it is preferable for the distal face of the vibration tool 27to be adapted exactly to the proximal face of the fusion device, e.g. bycomprising a concave curvature corresponding exactly with the convexcurvature of the proximal face of the fusion device F. In an areabetween the distal end and the proximal end the vibration tool has across section which is substantially the same as the outer cross sectionof the gap finder 20, of the drill guide 22, of the cutter guide 24 andof the control tool 26. The vibration tool 27 may comprise a depth stop41 like the drill 23 and the cutter 25, which depth stop 41 cooperatese.g. with the proximal face of the guide bush 21 or with a correspondingstop shoulder inside the axial tunnel 32 of the guide bush. For givingthe surgeon more freedom regarding implantation depth it may beadvantageous to not equip the vibration tool 27 with a depth stop, butrather with one or a plurality of depth marks (not shown) which show thesurgeon how deep the fusion device is introduced in the joint at anymoment during implantation.

It is also possible to design the combination of vibration tool 27,fusion device F and guide bush 21 or part thereof as a load framecontaining a biased spring which is released for the implantation stepto provide the axial force and stroke necessary for the implantationstep. Suitable such load frames are disclosed in the U.S.-applicationNo. 61/033,066, the disclosure of which is enclosed herein by reference.

Implantation of the fusion device according to FIGS. 1A to 1C in apreferably minimally invasive or mini-open procedure with the aid of thetool set according to FIGS. 4A to 4H comprises the following steps,which are schematically illustrated in the flow diagram of FIG. 5:

Finding and marking the gap between the articular surfaces bypositioning the protrusions 30 of the gap finder 20 in the gap, whereinthe gap finder 20 is possibly introduced along a previously positionedK-wire.

Positioning and fixing the guide bush 21 on the bone surface on bothsides of the gap by introducing the gap finder 20 into the axial tunnel32 of the guide bush 21, by pushing the guide bush 21 against the boneuntil it abuts the bone surface, and by punching the spikes 33 or bladesof the guide bush 21 into the bone surface using the punch 34.

Removing the gap finder 20.

Positioning the drill guide 22 in the axial tunnel 32 of the guide bush21, making sure that its distal face abuts on the bone surface.

Positioning the drill 23 in one of the axial bores 35 of the drill guide22, drilling the first bore and repeating positioning and drilling forthe second bore, wherein the predefined depth of the bores is reachedwhen the depth stop 37 of the drill 23 abuts on the stop shoulder 36 ofthe drill guide 22.

Removing the drill 23 and the drill guide 22 from the guide bush 21.

Positioning the cutter guide 24 into the axial tunnel 32 of the guidebush 21 making sure that its distal face abuts on the bone surface.

Positioning the cutter 25 into the axial tunnel 38 of the cutter guide24 and activating it and, if applicable, moving it laterally in theaxial tunnel 38 of the cutter guide 24, wherein the predefined depth ofthe tissue removal by cutting is reached when the depth stop 40 of thecutter 25 abuts on the stop shoulder 39 of the cutter guide.

Removing the cutter 25 and the cutter guide 24 from the guide bush 21.

Controlling the accuracy of the preparation of the joint by introducingthe control tool 26 into the axial tunnel of the guide bush 21 andchecking the introduction depth and removing the control tool.

If the controlled introduction depth is not o.k., repeating the steps ofintroducing the drill guide 22, of introducing the drill 23 and ofdrilling, the steps of introducing the cutter guide 24, of introducingthe cutter 25 and of tissue removal, and the steps of introducing thecontrol tool 26 and of checking the introduction depth.

If the controlled introduction depth is o.k., introducing the vibrationtool 27 with the fusion device F mounted to its distal end into theaxial tunnel 32 of the guide bush 21 and vibrating the tool 27 andtherewith the fusion device F while introducing the fusion device intothe space prepared in the steps of drilling and cutting between thearticular surfaces, wherein a predetermined depth of introduction isreached when the depth stop 41 of the vibration tool 27 abuts on theproximal surface of the guide bush 21 or a freely selectableintroduction depth is reached when a corresponding mark on the vibrationtool has reached the proximal face of the guide bush 21.

Separating the vibration tool 27 from the anchored fusion device F andremoving it from the guide bush 21.

Removing the guide bush 21.

The step of controlling the joint preparation using the control tool isnot an obligatory step.

In a preferred tool set, the tools have the following further features,which may cooperate with further tools: For x-ray control of the correctposition of its distal protrusions in the joint gap, the facet finder 20(except for its distal protrusions) should have a sufficienttransparency for x-rays through its length and at the same time needs asufficient mechanical stiffness. Therefore it is proposed to e.g.manufacture the facet finder 20 of PEEK and to increase its transparencyby providing a plurality of through openings along its length, or tomanufacture it as a sandwich construction with two relatively thin rigidsurface layers (e.g. made from carbon or glass fiber reinforcedlaminates) oriented parallel to the longer extension of the crosssection and a center layer of foamed material (e.g. polyurethane foam)for better transparency. The guide bush 21 is designed to have a firstaxial length and in the region of its proximal end it comprises meansfor removeably fixing a laterally extending handle piece. The facetfinder 20 has an axial length which is greater than the first axiallength and it comprises a through opening situated beyond the proximalface of the guide bush 21 when the facet finder 20 is positioned in theguide bush. For removing the facet finder 20 from the guide bush 21, thedistal end of an angled remover tool (not illustrated) is introducedinto the through opening and is pivoted upwards while the remover toolis supported on the proximal face of the guide bush 21. The punch 34 hasan axial channel of the same cross section as the axial channel of theguide bush 22 and an axial length such that the guide bush 21 and thepunch 34 together have and axial length which is larger than the axiallength of the facet finder 20 such that the punch 34 can be positionedover the proximal end of the facet finder being positioned in the guidebush 21. The drill guide 22 and the cutter guide 24 have proximalflanges which rest on the proximal face of the guide bush 21 when thedistal end is positioned against the bone surface.

FIGS. 6A to 6C illustrate a preferred embodiment of guide bush 21,cutter guide 24′, and cutter 25, which are operable for removing tissuebetween the two bores drilled with the aid of the drill guide and thedrill. FIGS. 6A and 6B show the cutter guide 24′ and the cutter 25positioned in the guide bush 21, wherein FIG. 6A is an axial sectionparallel to the longer extension of the inner cross section of the guidebush and FIG. 6B an axial section parallel to the shorter extension ofthe cross section of the guide bush. FIG. 6C is a three-dimensionalillustration of the assembly of cutter 25 and cutter guide 24′. In thisembodiment, the cutter guide 24′ comprises a disk 42 with two bolts 43arranged to extend coaxially to the disk on both sides thereof and theguide bush 21 comprises two opposite slots 44, the slots 44 reachingdistally from the proximal face of the guide bush. The disk 42 comprisesa radial bore through which the cutter shaft extends being capable tomove longitudinally and to be rotated relative to the disk 42. The disk42 has a diameter which is adapted to the longer extension of the innercross section of the guide bush 21 and a thickness which is adapted tothe smaller extension of the inner cross section of the guide bush 21.The axial bolts 43 have a cross section which is adapted to the width ofthe slots 44. The cutter 25 with the disk 42 loosely arranged thereon(e.g. loosely held in place between two thicker portions 25.1 and 25.2of the cutter shaft (FIG. 6C)), is introduced into the guide bush 21,the disk 42 guiding the cutter 25 in the axial channel of the guide bush21 and the bolts 43 sliding along the slots 44 until they come to reston the rounded ends of these slots. In this position of the disk, thecutter is capable of moving longitudinally between two positions definedby the thicker portions 25.1 and 25.2 and to be rotated. Furthermore, itis capable of being pivoted, the bolts 43 and the ends of slots 44serving as pivot bearing, the disk 42 serving as centering guide and theguide bush 21 limiting the pivotal movement of the cutter 25. Theremoval of tissue is preferably finished, when the cutter 25 has reachedits most distal position relative to the disk 42.

FIG. 7 is an axial section on a larger scale than FIG. 4H of the distalend of the vibration tool 27 and a fusion device similar to the oneillustrated in FIGS. 1A to 1C being mounted thereon for implantation.The fusion device is held on the distal tool end by protrusions 51extending from the distal tool face and being adapted to enter theopenings 5 in the proximal face 4 of the fusion device. As alreadymentioned further above, for optimal transfer of the vibration to thefusion device and therewith optimal anchorage of the fusion device inthe bone tissue it is preferable that the form of the distal tool facematches the form of the proximal face 4 of the fusion device as exactlyas possible, such enabling transfer of the vibration from the tool 26 tothe fusion device over the whole distal tool face.

The fusion device according to FIGS. 1A to 1C and 7, the implantationmethod according to FIGS. 2A to 2D, 3 and 5 and the tool set accordingto FIGS. 4A to 4H can be modified in e.g. the following manner, withoutdeparting from the basic idea of the invention:

The stabilization portion 2 of the fusion device is bent or bendable tobe not straight and non-parallel to the device width W, the fusiondevice therewith being adapted or adaptable to fit more convex/concavearticular surfaces (necessitates corresponding adaptation of the drillguide 22, the cutter guide 24, the control tool 26 and the vibrationtool 27, and possibly of the gap finder 20 such that the protrusions 30define a curved line instead of a straight line);

Both the anchorage portions 1 and the stabilization portion 2 of thefusion device are substantially made of a liquefiable material (see FIG.8), wherein the device portions may be made of the same liquefiablematerial or different such materials, and wherein the stabilizationportion 2 may carry a coating of a material which is capable ofenhancing osseointegration. Such coating may e.g. comprise calciumphosphate or apatite;

Both the anchorage portions 1 and the stabilization portion 2 are madesubstantially of a non-liquefiable material, e.g. of titanium or atitanium alloy or of a ceramic material. The non-liquefiable material ispreferably treated to have a surface structure, which in the region ofthe stabilization portion 2 enhances osseointegration and which in theregion of the anchorage portions 1 is suitable for adherence of an atleast partial coating comprising the liquefiable material. Anchorageportions comprising a metal core have the advantage of being visiblewith X-ray and therewith facilitating implantation. Such cores may alsobe removable after implantation.

The anchorage portions 1 have non-round cross sections (may necessitateadaptation of the drill guide 22 and possibly of the drill 23, which maybe replaced by e.g. a vibration driven punching tool as disclosed in thepublication US 2008/269649).

The proximal device face is not adapted to a curved rim of an articularsurface but is e.g. straight and extending e.g. perpendicular to theimplantation direction (necessitates corresponding adaptation of thedistal face of the vibration tool 27).

The proximal face of the anchorage portions 1 does not comprise openings5 adapted to corresponding protrusions 51 of the vibration tool 27 butvice versa or this proximal face is even. Further means and ways forattaching the fusion device to the distal end of the vibration tool aredisclosed in the above named publications U.S. Pat. No. 7,335,205 andU.S. Pat. No. 7,008,226.

The distal regions of the anchorage portions 1 and/or of thestabilization portion 2 are not tapering or the anchorage portions 1and/or the stabilization portion 2 taper continuously or in steps overtheir whole depth, i.e. from the proximal face to their distal end(necessitates corresponding adaptation of the drill 23 and possibly ofthe drill guide 22).

The difference in thickness between the anchorage portions 1 and thestabilization portion 2 is small (<1 mm) and/or the anchorage portionsare equipped with self-reaming structures, such enabling implantationwithout the necessity of providing grooves 11 (use of the drill guide 22and the drill 23 may be eliminated).

In the preparation step, larger portions of the articular cartilage isremoved and larger portions of the articular surfaces are decorticated(necessitating further, per se known tools, which are preferably usedbefore fixation of the guide bush 21 and possibly the facet finder 20).

The tissue between the two bores is not removed (use of the cutter guide24 and the cutter 25 may be eliminated).

The stabilization portion and/or the anchorage portions are made of aresorbable material to be gradually replaced by bone growth duringresorption.

The fusion device is a three-part (or multi-part) device comprising two(or more than two) anchorage portions and one stabilization portionconstituting three (or more than three) separate device parts, whereinthe stabilization portion is first positioned between the articularsurfaces and the anchorage portions are then pushed through or past thestabilization portion to be anchored in the bone tissue and possibly inthe stabilization portion (see also FIGS. 12 to 14; necessitating asecond vibration tool if the stabilization portion comprises aliquefiable material and is to be anchored in the tissue of thearticular surfaces, or necessitating a suitable punch, if thestabilization portion is made of a non-liquefiable material and isimpacted into the gap between the articular surfaces).

The fusion device is a three-part device comprising two anchorageportions and one stabilization portion constituting three separatedevice parts, wherein the anchorage portions are first implanted(preferably simultaneously) and the stabilization portion is then fixedto the two proximal faces of the implanted anchorage portion(necessitating a second vibration tool if the stabilization portioncomprises a liquefiable material and is fixed to the anchorage portionsby ultrasonic welding, or necessitating a suitable punch, if thestabilization portion is made of a non-liquefiable material and isimpacted into the proximal faces of the implanted anchorage portions).

The fusion device comprises two separate anchorage portions and nostabilization portion, wherein the two anchorage portions are preferablyimplanted simultaneously (use of cutter guide 24 and cutter 25 can beeliminated).

The fusion device comprises one anchorage portion and no stabilizationportion (drill guide 22 and vibration tool 27 may possibly be adapted,use of cutter guide 24 and cutter 25 can be eliminated).

The anchorage portion(s) comprise the liquefiable material on one sideonly and/or the cartilage is removed from only one articular surface,such that the anchorage portion(s) is anchored only in one articularsurface (possibly necessitating adaptation of the drill guide 22 anddrill 23 as well as cutter guide 24 and cutter 25).

The one- or three-part fusion device is not anchored in the bone tissuebut is simply pushed between the two articular surfaces, wherein theanchorage portions of the fusion device may comprise barbs, resilientprotrusions or other per se known retaining means; in a three-partfusion device, the separate anchoring portions may be equipped with athread and be pushed between the articular surfaces under rotation (thevibration tool 27 may be adapted to be a simple positioning tool or maynot be vibrated but e.g. rotated for the implantation step).

The one- or three-part fusion device is anchored in the bone tissueusing electromagnetic radiation (preferably in the visible or infraredfrequency range) instead of vibration energy for liquefaction of theliquefiable material. For this purpose, instead of the vibration tool27, a non-vibrating positioning tool is used, the positioning toolhaving the same form as the vibration tool and further comprising lightguides with proximal ends being connected to a radiation source (e.g.laser) and distal ends arranged at the distal tool face in a mannersuitable for coupling the laser light into the anchorage portions of thefusion device. Furthermore, the anchorage portions are designed tocomprise in a central region a material which is transparent for thelaser light and capable of scattering it, and near the surfaces whereliquefaction is to occur a material capable of absorbing the laser lightfor creating the thermal energy needed for the liquefaction andanchoring. The anchorage portions consist e.g. of one thermoplasticmaterial which in a pure state is transparent for the laser light andwhich in the central region contains a scattering agent and in aperipheral region an absorbing agent, the agents being e.g. particulateor molecular. In FIG. 7, the left hand side of the tool is showncomprising a light guide 45 (dash-dot lines) and the left hand anchorageportion comprising a central region 46 with a scattering agent(indicated by short lines of varying orientation) and a surface region47 with an absorbing agent (indicated by small circles). The two agentsneed to be adapted in a per se known manner to the electromagneticradiation to be coupled into the anchorage portion. The radiation sourceis activated shortly before, during or after the device is positionedbetween the articular surfaces. During liquefaction, a pressing force isapplied to the pushing tool for making the liquefied material penetrateinto the bone tissue.

The one- or three-part fusion device comprising two anchorage portionsand one stabilization portion is implanted with its width orientedperpendicular or at an oblique angle to the articular surfaces, i.e. notin the gap between the articular surfaces but across it (see also FIGS.19 and 20; necessitates adaptation of the gap finder 20 by orienting theprotrusions non-parallel to the largest cross section diameter but e.g.perpendicular to it).

FIG. 8 is a three-dimensional illustration of a fusion device based onthe same principle as the device illustrated in FIGS. 1A to 1C. Thefusion device comprises two anchorage portions 1 and one stabilizationportion 2, arranged between the anchorage portions 1. The whole deviceis preferably made of a resorbable thermoplastic polymer (e.g. ofpolylactide, preferably LR706 by Böhringer). The anchorage portions 1are slightly tapering and comprise a pointed distal end, the surface ofthe slightly tapering region being equipped with energy directors e.g.in the form of short axial ridges arranged in a plurality of adjacentrings, wherein the ridges of one ring are staggered in relation to theridges of the adjoining ring or rings. Similar arrangements of energydirectors are described in the publication US 2008/0109007 whose contentis enclosed herein by reference. The fusion device is preferablyimplanted using vibrational energy, wherein the bores provided in thearticular surfaces are preferably stepped and wherein the device and thebores and the tissue removal therebetween are preferably dimensionedsuch that liquefaction and anchorage between device and bone tissueoccurs not only on the surface of the anchorage portions 1, but also onthe surface of the stabilization portion 2. This means that the deviceis slightly oversized in comparison with the prepared joint gap, butbecause of the liquefaction no press-fit is achieved. On the other handit is of course possible also to implant the same device withoutliquefaction, i.e. by simply impacting the device into the preparedjoint gap where the device is retained by a press fit at least in theregion of the anchorage portions.

The openings 5 extending axially from the proximal device face into theanchorage portion serve for holding the device on the distal end of avibration or positioning tool, as discussed in connection with FIGS. 1Ato 1C. In the case of a fully thermoplastic and therewith x-raytransparent fusion device, it is advantageous to design these openingsdeeper and to position marker elements therein. These marker elementscomprise a material which is visible e.g. for an x-ray control of thedevice position after implantation. They consist e.g. of titanium,tantalum or another suitable metal or they comprise a bioresorbablematerial, such as e.g. a composite material of barium sulfate in PLA,which is eventually resorbed together with the rest of the fusiondevice.

If a fusion device, which is fully made of a suitable thermoplasticmaterial, in particular of such a material having a relatively low glasstransition temperature, is implanted with the aid of vibrational energyor another suitable type of energy, it is possible to introduce enoughof the energy for bringing portions of the material above the glasstransition temperature (in addition to liquefying surface material) suchthat they are capable of being slightly deformed and therefore betteradapted to the form of the implantation site. Such deformation may e.g.concern the anchorage portions which may e.g. become slightly bent suchbeing better adapted to articular surfaces without bores or to boreshaving non-straight axes due to slight movement of the articularsurfaces relative to each other during implantation or it may concernthe stabilization portion.

FIG. 9 shows a further exemplary embodiment of the fusion deviceaccording to the invention. The fusion device has approximately the sameform as the fusion device shown in FIGS. 1A to 1C, but the anchorageportions 1 do not consist fully of the liquefiable material or comprisethis material on their surfaces but they comprise a perforated sheath 52each and the liquefiable material is provided inside these sheaths 52,e.g. in the form of a polymer pin.

The method for implanting the fusion device as shown in FIG. 9 isdifferent from the method for implanting the fusion device as shown inFIGS. 1A to 1C in that the fusion device needs to be positioned betweenthe prepared articular surfaces and only then the liquefiable materialis liquefied by being pressed into the sheath 52 and simultaneouslybeing impinged with mechanical vibration. On liquefaction, the materialis pressed through the perforated walls of the sheaths 52 to penetrateinto the bone tissue in the liquid state. For such liquefaction andpressing out, a vibration tool 27 is applied to the liquefiable materialonly, which vibration tool 27 may comprise a forked distal end equippedfor holding and guiding the fusion device on being introduced into thejoint and for transmitting vibrational energy to the liquefiablematerial of both anchorage portions 1 simultaneously. It is alsopossible to employ separate tools for positioning the fusion device andfor vibrating the liquefiable material, wherein the vibration tool mayhave only one distal end (as illustrated) and the two anchorage portionsare anchored in the bone tissue one after the other.

It is also possible to use mechanical vibration not only for liquefyingthe liquefiable material contained in the sheaths 52 but also forfacilitating the positioning of the fusion device according to FIG. 9between the prepared articular surfaces, which is achieved by using anadditional vibration tool (not shown) suitable for transmitting thevibration to the sheaths of the anchorage portions and/or to thestabilization portion (vibration tool 27 e.g. as shown in FIG. 7).

It is also possible to first position the fusion device between thearticular surfaces without the liquefiable material being present in thesheaths 52 using a corresponding positioning or vibration tool and onlythen introducing the liquefiable material constituted by two polymerpins adapted to the inner cross section and length of the sheaths 52 andapplying the vibrational energy thereto.

The embodiment as shown in FIG. 9 also allows using a bone cementinstead of the liquefiable material, or a polymer of a high viscosity,wherein the cement or polymer is made to harden when pressed out of thesheath and into the bone tissue of the articular surfaces.

Instead of vibrating the liquefiable material positioned in the sheaths52, it is possible also to couple a pin comprising the liquefiablematerial to a rotation drive, to introduce a distal portion of the pininto the sheath 52 and to liquefy the material by rotating the pinwithin the sheath 52 and at the same time pressing it into the sheathand holding the sheath for preventing it from rotating with the rotatingpin, such creating friction at least at the distal pin end and therewiththermal energy which liquefies the pin material.

Furthermore, as already mentioned in connection with the fusion deviceaccording to FIGS. 1A to 1C and 7, it is possible also to couple,instead of vibrational or rotational energy, electromagnetic radiation(preferably of the visible or infrared frequency range) into theliquefiable material which is e.g. equipped for scattering the radiationand transmitting it into the sheath (e.g. made of metal) where it isabsorbed to create thermal energy which is able to liquefy thethermoplastic material at least partly. Absorption may also take placewithin the pin which for this purpose contains an absorbing agent. It ispossible also to design the sheath such that at least an inner surfacethereof can be heated electrically.

FIG. 10 shows a further exemplary embodiment of the fusion deviceaccording to the invention and the distal end of a vibration tool 27suitable for implantation of the fusion device. The anchorage portionsof the fusion device are anchored in the bone tissue of the articularsurfaces using the anchoring technique as described in the publicationWO 2009/055952. The anchorage portions 1 have the form of polymer tubes57 and distal ends of the vibration tool 27 protrude through the tubes57 and, adjacent to the distal ends of the tubes, carry distal footpieces 58 which consist of the same polymer material as the tubes 57 orof a different polymer material being weldable to the polymer materialof the tubes. This is shown on the left hand side of FIG. 10.

The foot pieces 58 are fixed to the vibration tool 27 via a connection(e.g. threads) which is able to transmit the vibrational energy from thetool 27 to the foot piece 58 and which is capable of being destroyedwhen the foot piece 58 is sufficiently warmed by the vibrational energy.

For the implantation, the fusion device as shown in FIG. 10 is held andguided between the articular surfaces with the aid of the vibration tool27 and is held in place by a counter element 59. The vibration tool 27is then vibrated and simultaneously pulled in a direction away from thefusion device. Through the vibrational energy, the liquefiable materialof the distal end of the tubes 57 and/or of the proximal face of thefoot pieces 58 is liquefied and penetrates into the bone tissue.Therewith the tubes 57 get shorter and are eventually welded to the footpieces 58. As soon as a sufficient amount of the liquefiable material isliquefied and the foot pieces 58 are warm enough, the pulling force onthe vibration tool 27 is increased for separating the distal tool endsfrom the foot pieces 58, which remain anchored in the bone tissue toconstitute distal ends of the anchorage portions 1 as shown on the righthand side of FIG. 10.

A similar implantation result can be achieved by using, instead ofvibrational energy, electromagnetic radiation which is coupled e.g.through the counter element 59 into the polymer tube 57 or through apushing tool of the same form as the illustrated vibration tool 27 intothe foot piece 58 to be absorbed in a distal part of the polymer tube 57or in the foot pieces 58 of the tool, in the same manner as describedfor the fusion device as illustrated in FIGS. 1A to 1C and 7.

FIG. 11 shows an anchorage portion 1 of a further exemplary embodimentof the fusion device according to the invention as well as a distal endportion of a vibration tool 27 suitable for implantation of the fusiondevice. The fusion device may have a similar form as the fusion deviceaccording to FIGS. 1A to 1C. The anchorage portion 1 of the fusiondevice is designed for being anchored in the bone tissue of thearticular surfaces using the anchoring technique as described in theprovisional U.S. application No. 61/049,587, the content of which isenclosed herein by reference. This anchoring technique is a combinationof the anchoring techniques as shortly described in connection withFIGS. 9 and 10. For this reason, the anchorage portion 1 comprises aperforated sheath 52 and the liquefiable material is provided inside thesheath 52 in the form of a polymer tube 57 through which the distal endof the vibration tool 27 reaches, carrying a distal foot piece 58 beyondthe polymer tube 57. The polymer tube 57 is held in place inside thesheath 52 with a counter element 59. For anchoring it in bone tissue,the anchorage portion 1 as shown in FIG. 11 is positioned between thesuitably prepared articular surfaces of the joint to be fused, thepolymer tube being held in place with a counter element 59. Then, thevibration tool 27 is pulled in a direction away from the bone tissue andis vibrated, such that the polymer material is liquefied between thedistal face of the polymer tube 57 and the proximal face of the footpiece 58 and is pressed through the sheath perforations to penetrateinto the bone tissue outside the sheath 52. Therein it is possible toequip the sheath with perforations at a plurality of distinct depths andto liquefy polymer material in these distinct depth in distinctliquefaction steps between which the foot piece is moved from one suchdepth to a next higher one, the vibration being switched off After alast liquefaction step the counter element 58 and the vibration tool 27are removed from the sheath 52, wherein a rest of the polymer tube 57and the foot piece 58 remain in the sheath 52 (similar to the anchoringprocess as described in connection with FIG. 10) or are removed from thesheath. In the latter case the foot piece 58 may, as illustrated, bemade of a non-liquefiable material.

In the same manner as described further above for the fusion devices asillustrated in FIGS. 1A to 1C, and 7 to 10, implantation of the fusiondevice comprising anchorage portions as illustrated in FIG. 11 ispossible also with the aid of radiation energy (preferably laser lightof the visible or infrared frequency range) or rotational energy insteadof the above described vibrational energy. For the latter case, apushing tool of the same form as the above described vibration tool 27is used and the pushing tool is connected to a rotation drive, while thecounter element 59 is equipped for not only holding the polymer tube 57against the foot piece 58 but also for preventing the polymer tube fromrotating together with the tool. Friction heat created between thedistal face of the non-rotating polymer tube 57 and the proximal face ofthe rotating foot piece 58 liquefies the distal end of the polymer tubeand makes the liquefied material pass through the perforations of thesheath 52. Furthermore, liquefaction can be achieved by couplingelectromagnetic radiation e.g. into the counter element 59 and fromthere into the polymer tube 57 to be absorbed in the polymer tube 57 orin the foot piece 58. A further way for creating the thermal energyneeded for the liquefaction consists in electrically heating theproximal face of the foot piece 58.

FIG. 12 shows a further embodiment of the fusion device according to theinvention which fusion device, when implanted, resembles the fusiondevice according to FIGS. 1A to 1C or 7, but before implantationcomprises the anchorage portions 1 and the stabilization portion 2 asseparate parts (three-part device or possibly multi-part device). Thestabilization portion 2 is designed for being introduced into the gapbetween the articular surfaces and for being then fixed by introducingthe anchorage portions 1 (preferably simple polymer pins) through bores55 in the stabilizing portion 2 and anchoring them then in the bonetissue. The stabilization portion 2 is preferably substantially wedgeshaped and comprises two (or more than two) through bores 55 extendingfrom the proximal face 4 to a distal face and preferably having adiameter which is smaller than the thickness of the stabilizationportion 2 at the proximal face 4 and larger than the thickness of thestabilization portion 2 at the distal face such that the distal boremouths extend from the distal face onto the lateral surfaces of thestabilization portion 2 towards the proximal face.

FIG. 12 shows on the left hand side the anchorage portions 1 beforebeing introduced in the bores 55 of the stabilization portion 2, i.e. itshows the fusion device before implantation, and on the right hand sidea section through the fusion device after implantation. For theanchorage portions 1 being able to fix the stabilization portion 2firmly in the gap between the articular surfaces, it is advantageous toprovide in the bores 55 of the stabilization portion 2 a furtherliquefiable material which is welded to the liquefiable material of theanchorage portions on implantation, or a surface structure, into whichthe liquefiable material of the anchorage portions is pressed onimplantation. A similar effect can be achieved by equipping theanchorage portions 1 with heads, or, as illustrated, to form such heads56 by applying further vibrational energy for plasticizing andcorrespondingly deforming the material of the proximal end of theanchorage portions 1.

For providing the grooves in the bone tissue of the articular surfacesfor accommodating the distal ends of the anchorage portions, it ispossible to use a drill guide as shown in FIG. 4C or to use thepositioned stabilization portion 2 of the device as drill guide.

As already described for the fusion device as illustrated in FIGS. 1A to1C and 7, it is possible for the fusion device according to FIG. 12 touse for the implantation or the liquefaction of the liquefiable materialrespectively, instead of vibrational energy, electromagnetic radiationand to provide means for absorbing such radiation in or adjacent to thelocation in which such liquefaction is desired. For such purpose, thestabilization portions 1 comprise an absorbing agent or the radiation isabsorbed by the stabilizing portion 2.

Instead of the anchorage portions as illustrated in FIG. 12 to beanchored in bores between the articular surfaces and possibly welded inthe stabilization portion with the aid of a liquefiable material ande.g. vibrational energy, it is possible also to use anchorage portionsas illustrated in FIGS. 9 to 11 or per se known interference screws.

FIGS. 13A to 13D show further embodiments of the three-part ormulti-part fusion device according to the invention, the embodimentsbeing based on the same principle as the fusion device according to FIG.12. A first embodiment is illustrated in FIGS. 13A (viewed from the sideof the proximal face, after implantation) and 13B (in section, sectionplane designated with B-B in FIG. 13A, in partly implanted state), and asecond embodiment is illustrated in FIGS. 13C (viewed from the side ofthe proximal face, after implantation) and 13D (in section, sectionplane designated with D-D in FIG. 13C, before and after implantation).In contrast to the fusion device illustrated in FIG. 12, the anchorageportions 1 of the devices according to FIGS. 13A to 13D do not extendthrough openings in the stabilization portion 2 but are positioned onboth sides of the stabilization portion, wherein a bore (or opening withanother than circular cross section) adapted to receive one of theanchorage portions is preferably situated partly in the stabilizationportion (groove 60) and partly in the bone tissue (opening 11, beinggroove in a proximal region).

As for the fusion device according to FIG. 12, the fusion devicesaccording to FIGS. 13A to 13D are implanted by firstly pushing thestabilization device into the joint gap and by then positioning theanchorage portions and anchoring them in the bone tissue. Therein theopening/grooves 11 to be provided in the bone tissue of the articularsurfaces may be made before positioning the stabilization portion 2 inthe joint gap using a drill guide e.g. as illustrated in FIG. 4C or theymay be made after positioning the stabilization portion 2 in the jointgap, using the stabilization portion as a drill guide.

The anchorage portions 1 of the fusion devices according to FIGS. 13A to13D are again anchored in the bone tissue with the aid of a liquefiablematerial, wherein the liquefiable material is arranged on the anchorageportions in any of the ways as discussed further above. Therein it isadvantageous to simultaneously, with the anchoring in the bone tissue,connect the anchorage portions with the stabilization portion, e.g. byproviding a suitably structured surface on the stabilization portionwhere the anchorage portions are to be attached and by providing theliquefiable material on both sides of the anchorage portions, on oneside for establishing a positive fit connection with the bone tissue andon the other side for establishing a positive fit connection with thesurface structure of the stabilization portion 2. Further examples ofmethods for in situ attaching device parts to each other andsimultaneously anchoring them in bone tissue are described in thepublication WO 2008/034276 which is incorporated herein in its entiretyby reference. Further such methods are discussed in connection withFIGS. 14A to 14C.

The fusion device according to FIGS. 13A and 13B comprises onestabilization portion 2 and four anchorage portions 1, wherein thestabilization portion 2 has e.g. the form of a wedge and comprises twogrooves 60 on either side for receiving the anchorage portions 1. Thefusion device according to FIGS. 13C and 13B differs from the fusiondevice according to FIGS. 13A and 13B by two anchorage portions beingconnected with a bridge element 61 to form a twin anchorage portion 1′.

The stabilization portions of the devices according to any of FIGS. 12to 13D are positioned in the joint gap by being pushed in with the aidof a positioning tool. It is possible also to use a screw arrangementcooperating with a thread which is provided in a through opening of thestabilization portion 2. Therein, the screw arrangement is to besupported on the bone tissue such that there is no axial displacement ofthe screw relative to the bone and, on rotating the screw, thestabilization portion is moved along the screw into the joint gap (corkscrew principle).

FIGS. 14A to 14C illustrate a further method for anchoring the anchorageportions 1 of the devices as illustrated in FIGS. 12 to 13D in the bonetissue and at the same time welding them to the stabilization portion 2.For this purpose, the stabilization portion comprises a liquefiablematerial at least in surface regions to be attached to anchorageportions 1, wherein this liquefiable material is to be weldable to theliquefiable material of the anchorage portions. All FIGS. 14A to 14Cshow the bone in section parallel to the implantation direction, part ofthe stabilization portion 2, the bone tissue 100 on one side of thestabilization portion 2 and one anchorage element 1 ready for beingpositioned between the bone tissue 100 and the stabilization portion 2and simultaneously being anchored in the bone tissue of the articularsurface and welded to the stabilization portion 2. Therein forpositioning the anchorage element 1, a groove 11 is provided in the bonetissue 100 and an opposite groove 60 in the stabilization portion 2.

According to FIG. 14A, at least the region of the groove 60 of thestabilization portion 2 comprises a coating 2.2 to which the liquefiablematerial of the anchorage portion is weldable under the implantationcondition, e.g. when the anchorage portion is pushed into the oppositegrooves and simultaneously vibrated (e.g. ultrasonic vibration).According to FIG. 14B, a plurality of thermoplastic pins 2.11, 2.12,2.13 is arranged in the groove 60 of the stabilization portion 2 insteadof the coating 2.2. It may be advantageous to arrange the thermoplasticpins 2.11, 2.12, 2.13 at different angles. According to FIG. 14C, thestabilization portion 2 carries one or a plurality of thermoplasticinserts 2.21, 2.22, comprising portions which protrude into groove 60and being suitable for being welded to the anchorage portion 1.

FIGS. 15 to 18 show further exemplary embodiments of the fusion deviceaccording to the invention, the devices comprising numbers of anchoringportions and/or stabilization portions which are different form suchnumbers of the embodiment according to FIGS. 1A to 1C. Virtually allabove comments regarding the fusion device, in particular the variousdesigns of the anchorage portions as shown in FIGS. 7 to 11, thecorresponding anchoring techniques, and the design of multi-part devicesas illustrated in FIGS. 12 to 13D are adaptable to these furtherembodiments of the fusion device in a straight forward manner.

The fusion device according to FIG. 15 comprises only one anchorageportion 1 and two stabilization portions 2, which are arranged onlateral sides of the anchorage portion 1, opposite each other and in aproximal region of the anchorage portion 1. The fusion device delimitswith concave contour areas two osteoconduction regions 3 being situatedbeside the distal region of the anchorage portion 1.

The fusion device according to FIG. 16 comprises two anchorage portions1 and a two-part stabilization portion 2 therebetween, theosteoconduction region 3 being delimited between lateral sides of theanchorage portions 1 and distal and proximal faces of the two parts ofthe stabilization portion 2.

The fusion device according to FIG. 17 comprises two anchorage portions1 and three stabilization portions 2, three osteoconduction regions 3being defined by through openings in the stabilization portions 2.

The fusion device according to FIG. 18 comprises two anchorage portions1 and one stabilization portion 2 joined to the anchorage portion 1 in acentral region between the distal and proximal ends thereof. Twoosteoconduction regions 3 are delimited by proximal and distal regionsof the anchorage portions 1 and proximal and distal faces of thestabilization portion 2.

FIGS. 19 and 20 illustrate the already above mentioned furtherembodiment of the method according to the invention, wherein a fusiondevice comprising two (or more than two) anchorage portions 1 and atleast one stabilization portion 2 between anchorage portions isimplanted not in the gap between the articular surfaces of the joint tobe fused, but across this gap, i.e. the width of the fusion device beingoriented at a right angle (FIG. 19) or at an oblique angle (FIG. 20)relative to the gap, the anchorage portions of the fusion device beinganchored in openings 13 being provided in the bone tissue on either sideof the gap between the articular surfaces and at a distance from thecartilage layer of the articular surfaces. Therein, for fusing onejoint, one fusion device may be implanted (FIG. 19) or a pluralitythereof (two fusion devices as shown in FIG. 20). The implantationprocess for fusing a joint as illustrated in FIGS. 19 and 20 is carriedout in quite the same way as implantation as illustrated in FIGS. 2A to2D. Therein tools similar to the tools shown in FIGS. 4A to 4H areapplicable, the gap finder being adapted such that the arrangement ofthe gap finding protrusions is oriented at a right or oblique angle tothe longest cross section extension of the tool.

Implantation as illustrated in FIGS. 19 and 20 is particularlyadvantageous for fusing synovial joints comprising articular surfaceswith small radius curvatures and being exposed to relatively high torqueloads, i.e. for synovial joints such as small pivot joints or saddlejoints (e.g. human finger joints and toe joints), wherein a non-parallelarrangement of two fusion devices as illustrated in FIG. 20 furtherenhances the rigidity achieved by the arthrodesis.

Example

Fusion devices as shown in FIGS. 1A to 1C and dimensioned for fusion ofa human facet joint were implanted between two pieces of “saw bone”™,each one comprising two grooves for accommodating the anchorage portionsof the fusion device. The fusion devices consisted fully of PLDLA andwere pushed between the saw bone pieces with the aid of an ultrasonichandpiece of Branson (Branson LPe 20 kHz, 150 W with converter TW1 andBranson LPe 30 kHz, 500 W with converter Palm). Good anchorage resultswere achieved with amplitudes of 20 to 40 micrometers (measured on thedistal side of the implant), a power of 10 to 60 W and pushing forces inthe range of 30 to 50N. Therein implantation with 20 kHz seemed moreadvantageous as the fusion device remained fully rigid throughout theimplantation process, in particular no softening in the region of theproximal device face was observed.

1. A fusion device for fusing a joint of a human or animal patient,wherein the joint is a synovial joint comprising two articular surfacesbetween two bones and a gap therebetween, the fusion device comprising:at least one anchorage portion and at least one stabilization portion,wherein the anchorage portion and the stabilization portion constituteseparate parts wherein the fusion device has an overall depth parallelto an implantation direction, the overall depth extending from aproximal face to a distal end of the fusion device, an overall width anda thickness profile perpendicular to the implantation direction, whereinthe at least one anchorage portion comprises a thermoplastic materialthat is liquefiable from a solid state to a flowable state uponapplication of energy, the thermoplastic material being arranged on asurface of the anchorage portion or inside a perforated sheathconstituting a part of the anchorage portion, and wherein the at leastone anchorage portion is configured to be positioned and anchoredbetween the articular surfaces in the joint first, and the stabilizationportion is capable of being mounted on the proximal end of the at leastone anchorage portion or wherein the stabilization portion is configuredto be positioned between the articular surfaces first, and the anchorageportion is capable of being pushed through or past the stabilizationportion and anchored in the bone tissue beside the stabilization portionor beyond the stabilization portion or both, beside and beyond thestabilization portion.
 2. The fusion device according to claim 1,wherein the stabilization portion, possibly together with the anchorageportion forms a concave device contour and therewith delimits anosteoconduction region.
 3. The fusion device according to claim 2,wherein a material furthering bone growth is arranged in theosteoconduction region, or device surfaces in the concave device contourcomprise means for holding such material.
 4. The fusion device accordingto claim 3, wherein the material furthering bone growth is at least oneof allograft or autograft bone material, a bone replacement material, asponge, and a BMP carrier.
 5. The fusion device according to claim 1,wherein the thermoplastic liquefiable material or a further deviceregion adjacent to the thermoplastic liquefiable material is capable ofabsorbing electromagnetic radiation energy of the visible or infraredfrequency range.
 6. The fusion device according to claim 1, wherein thewhole fusion device is made of the thermoplastic liquefiable material.7. The fusion device according to claim 1, wherein the stabilizationportion is equipped for furthering osseointegration by comprisingsurfaces which are equipped with a coating and/or a surface structurecapable of enhancing osseointegration.
 8. The fusion device according toclaim 1, wherein the depth of the anchorage portion is larger than thedepth of the stabilization portion.
 9. The fusion device according toclaim 8, comprising two pin-shaped anchorage portions and onestabilization portion, wherein the stabilization portion is designed forbeing fixed to proximal ends of the anchorage portions and to extendtherebetween, or the stabilization portion comprises through openings orgrooves for accommodating the anchorage portions.
 10. The fusion deviceaccording to claim 1, wherein a proximal device face comprises at leastone opening or protrusion and/or a convex curvature.
 11. The fusiondevice according to claim 1, wherein the thermoplastic liquefiablematerial is a material that has a modulus of elasticity of at least 0.5GPa and a melting temperature of at the most 350° C.
 12. The fusiondevice according to claim 1, wherein the stabilization portion comprisesa plurality of through bores for receiving the anchorage portions, thebores extending from a proximal face to a distal face of thestabilization portion and having a diameter that is smaller than athickness of the stabilization portion at the proximal face and largerthan a thickness of the stabilization portion at the distal face. 13.The fusion device according to claim 1, wherein the stabilizationportion comprises a plurality of grooves, and wherein the two anchorageportions are connected with a bridge element to form a twin anchorageportion.
 14. The fusion device according to claim 1, comprising at leasttwo of the anchorage portions, wherein the anchorage portions and thestabilization portion are arrangeable alternating over the width, theanchorage portions having a thickness being greater than the thicknessof the stabilization portion.
 15. The fusion device according claim 1,wherein the stabilization portion comprises a thermoplastic liquefiablematerial at least in surface regions to be attached to anchorageportion, wherein this thermoplastic liquefiable material is weldable tothe thermoplastic liquefiable material of the anchorage portion.
 16. Thefusion device according to claim 1, wherein the stabilization portion isrigid and configured to stabilize the joint to be fused immediatelyafter implantation.
 17. The fusion device according to claim 1, saidfusion device being configured for being implanted comprising the stepof transmitting energy to the liquefiable material for a time sufficientto liquefy at least part of the liquefiable material and to make theliquefied material to penetrate into pores, cavities or other structuresof the bone tissue of both articular surfaces in the region of said gapwhen in the flowable state and is able to form a positive fit connectionwith the bone tissue upon re-solidification.
 18. The fusion deviceaccording to claim 1, wherein the stabilization portion comprises aplurality of through bores for receiving the anchorage portions, thebores extending from a proximal face to a distal face of thestabilization portion and having a diameter that is smaller than athickness of the stabilization portion at the proximal face and largerthan a thickness of the stabilization portion at the distal face, orwherein the stabilization portion comprises a plurality of grooves, andwherein two of the anchorage portions are connected with a bridgeelement to form a twin anchorage portion.
 19. The fusion deviceaccording to claim 1, said fusion device being capable of mechanicallypreventing articular movement of the joint as well as preventingmovements due to shearing forces in all directions, movements doe totorque, and movements due to bending forces in planes other thanarticulating planes, while permitting micro movements of the two bonesrelative to each other that enhance osseointegration andosteoconduction.